Official Title: “Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Colesevelam HCl Administered to Pediatric Patients With Heterozygous Familial Hypercholesterolemia on a Stable Dose of Statins or Treatment Naive to Lipid-Lowering Therapy”

This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin, simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• Drug: colesevelam HCl
  • Tablets
• Drug: placebo
  • Matching Tablets

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • colesevelam HCl
• Experimental: 2
  • Low dose colesevelam
• Placebo Comparator: 3

Primary Measures

• Percent change in plasma LDL-C from study baseline (Day 1)to Week 8.
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Percent change in LDL-C from Week 8 to Week 26 and from study baseline (Day 1) to Week 26.
  • Time Frame: 26 weeks
    Safety Issue?: No

Inclusion Criteria:

• Male or female patients
• Ages 10 to 17 years inclusive
• Diagnosis of heterozygous familial hypercholesterolemia
• On a stable dose of statin monotherapy or are treatment naive to lipid- lowering agents
• On a low-cholesterol diet

Exclusion Criteria:

• Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Daiichi Sankyo Inc.

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00145574

Study ID Number: WEL-410

ClinicalTrials.gov Identifier: NCT00145574

Health Authority: United States: Food and Drug Administration